International Regulatory Affairs Specialist II – Electrophysiology (on-site)

Abbott Laboratories • Plymouth, MN

11d • $61,300 - $122,700 • Onsite

About The Position

Abbott is seeking an experienced Regulatory Affairs Specialist II to join its Electrophysiology business on-site in Plymouth, Minnesota. The role performs specialized regulatory work, including analysis, evaluation, preparation, and review of documentation for international regulatory registrations, primarily in China. It ensures products and procedures comply with applicable regulations and supports regulatory activities needed for product market entry.

Requirements

• Bachelor’s degree or equivalent.
• 2–3 years of experience in a regulated industry, such as medical products or nutritionals. Regulatory experience is preferred; experience in quality assurance, research and development/support, scientific affairs, operations, clinical, or a related area may also be considered. Higher education may compensate for years of experience.
• Ability to work in a team and complete projects in a fast-paced, matrixed environment.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Flexible schedule to attend meetings as needed with affiliates in other geographies.
• Strong problem-solving skills and the ability to think strategically and see the big picture.

Nice To Haves

• Bachelor’s degree in science (such as biology, chemistry, or microbiology), math, engineering, or a medical field.
• Master’s degree.
• Experience in the medical device industry.
• Experience working with NMPA (CFDA) or other international regulatory parties.
• Chinese/Mandarin language skills.
• Experience working in a broader enterprise or cross-division business-unit model.
• Adaptability and ability to switch priorities while completing tasks.
• Process-oriented approach.
• Regulatory Affairs certification, such as RAC from the Regulatory Affairs Professionals Society.

Responsibilities

• Assist in preparing regulatory applications, focused on China, to meet departmental and organizational objectives.
• Review medical device regulations for applicability and ensure submission requirements are current and recorded in regulatory submission databases and file systems; distribute information about new or modified requirements to appropriate personnel when requested.
• Determine and communicate regulatory submission and approval requirements and timelines to project teams.
• Evaluate proposed preclinical, clinical, design, and manufacturing changes and develop regulatory submission strategies.
• Track deliverables and follow up as needed to meet timelines.
• Provide regulatory impact assessments for changes to licensed products.
• Represent Regulatory Affairs in reviewing and analyzing applicable regulatory guidelines.
• Work across functions to develop documents and product information required for successful regulatory submissions.
• Assist with label development and review labels for compliance before release.
• Support product release by reviewing and approving product-release requests.
• Use judgment to select practical and innovative methods to resolve problems.
• Support business-segment initiatives identified by divisional management and support QMS, EMS, and other regulatory requirements.

Benefits

• Career development opportunities with an international company.
• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, offering an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level